Q2 2020 Amgen Inc Earnings Call

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Operator: To ask a question, please press star then the number 1 on your telephone keypad. To withdraw your question, press the pound key. I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may begin.

You asked a question. Please press Star then the number one on your telephone keypad to withdraw your question press the pound key.

I'd now like to introduce our of Institute Vice President of Investor Relations Mr. studio you may begin.

Arvind Sood: Thank you, Erica. Good afternoon, everybody, and welcome to our Q2 call. This call is going to feel a bit different than our previous earnings calls because we are making some changes. As a matter of fact, in response to feedback from many of you that our prepared comments are too long, we are going to limit our prepared comments to around 20 minutes. We'll also limit the duration of the call to one hour.

Thank you Eric Good afternoon, everybody and welcome to our Q2 calls this call is going to feel a bit different than our previous earnings calls because we're making some changes.

As a matter of fact in response to feedback from many of you better prepared comments are too long.

Well I can never thought prepared comments to about 20 minutes.

The duration of the caused one hour.

Arvind Sood: Now, that doesn't mean that we are scaling back on disclosure. You'll notice that our press release has been enhanced to provide explanations that were previously included in our prepared comments. We think this approach will free up time for Q&A, but to make sure that everyone has an opportunity to ask a question, we are still going to request that you stick to asking only one question.

That doesn't mean that fear scaling back on disclosure you'll notice a press release has been in rates to provide explanations that were previously included in our prepared comments.

We think this approach works we apply for acuity.

To make sure that everyone has an opportunity to ask a question you're still going to request that you stick to asking one question.

Arvind Sood: The slides have been posted but will not match up to our prepared comments given the brevity. Just a quick reminder that we'll use non-GAAP financial measures in our presentation and some of the statements will be forward-looking. Our 10-K and other filings identify factors that could cause our actual results to differ materially. So with that, I would like to turn the call over to Bob.

The flight Olson.

Match up to our proportionate to our prepared comments given the priority.

Just a quick reminder, that we use non-GAAP financial measures in our presentation at some of the states statements for before looking.

Our 10-K and other filings identify factors that could cause our actual results could differ materially so with that I would like to turn the call it over to Bob.

Bob: Okay, thank you Arvind and thank you everyone for joining today's call. As we look back at the first six months of the year and project forward to the second half, I'm very aware that we're still in the midst of a really significant global public health challenge and deep economic downturn. In that context, our results are given by 13% volume growth.

Okay. Thank you are.

Thank you everyone for joining todays call.

If you look back at the first six months a year project forward in a second half.

I'm very where that we're still in the midst of a really should never got no public health challenge and deep economic downturn.

In that context, our results, which includes 6% revenues growth.

Even by 13% volume growth.

These are strong results from they reflect the resilience of our people.

Bob: These are strong results, and they reflect the resilience of our people and our success in continuing to supply every patient every time with the medicines they need. We remain confident in the long-term growth potential of innovative medicines like Otezol, Repatha, Prolia, Avenidae, and Imavig, as well as our expanding portfolio of marketed biosimilars. Even in the second quarter, when we felt the depths of the pandemic.

Stryker operating systems.

And our success in continuing to supply every patient every time with the medicines they need.

We remain confident in the long term growth potential of innovative medicines like hotel so.

Hassle Prolia.

Vanity and there's nothing.

As well as our expanding portfolio marketed bio similars.

Even in the second quarter, when we felt the depths of a pandemic.

Bob: We deliver. Murdo will have more to say about that later, and also about how we're navigating commercially through what remains a very dynamic week-by-week situation, especially in the U.S. and other parts of the world. As we find new ways to meet the needs of current patients, we're excited about the potential of the medicines in our pipeline to enable us to serve many more patients in the future. We expect readouts in the second half of the year for soduracid, which of course is our AMG 510 in non-small cell lung cancer, tezapilumab in severe asthma, and omacamptide-micarbol in heart failure. Encouragingly, we've restarted many of the earlier stage clinical trials that we put on hold due to COVID-19 at the end of the first quarter and beginning of the second. We're also exploring Otesla as a potential treatment for patients with COVID-19. You'll hear Dave say more about that in a moment.

We delivered.

I will have more to say about out later and also about how we're navigating commercially through what remains a very dynamic week by week situation, especially in the U.S.

In other parts of thing.

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As we find new ways to meet the needs of current patients. We're excited about the potential the medicines in our pipeline to enable us to serve many more patients in the future.

We expect read outs in the second half of your for sort harassment, which of course, sorry, AMG 510 in non small cell lung cancer.

As a telling him out and severe asthma.

All the captive mccarville hersha.

Encouragingly, we restarted many of the earlier stage clinical trials that we put on hold due to cope with 19 at the end of.

First quarter beginning to sorry.

We're also exploring otezla so for potential treatment for patients with covert 19 here to say more about that in a moment.

In an environment of ongoing uncertainty our strong financial position provides us with competitive flexibility.

Murdo: In an environment of ongoing uncertainty, our strong financial position provides us with competitive flexibility. As Peter will discuss in a moment, our financial strength enables us to continue to invest in the long-term growth of our business, internally and externally, while also returning capital to our shareholders. We demonstrated tight control of expenses in the first half of the year. With health care systems operating more normally now, we expect to increase expenses, including for activities that were curtailed in parts of the first and second quarters. We're in a strong position heading into the second half of the year, and I just want to take a moment to thank the Amgen staff all around the world for their steadfast support of our mission. I also want to express our profound appreciation for all our partners in the healthcare community for the support that they've shown to the patients that we're trying to serve together. I look forward to answering your questions later on in our call, but right now, let me turn it over to Murdo.

Yes, Peter will discuss in a moment or financial strength enables us to continue to invest <unk> long term growth of our business internally and externally while also returning capital to our shareholders.

We demonstrated take control of expenses in the first half a year.

With health care systems operating more normally now.

Expected increase expenses, including for activities that were curtailed.

Parts of the first and second quarters.

We're a strong position heading into the second half of the year I just want to take a moment. The thing you have just staff all around the world. There are so fast support of our mission.

I also want to express our profound appreciation for all our partners in the health care community for the supports that they've shown to the patients that were trying to serve together.

For two answering your questions later in our coal, but right now let me turn over to Murdo.

Thank you Bob we continue to focus on growing volume across our diverse portfolio, while expanding our business geographically.

Murdo: Thank you, Bob. We continue to focus on growing volume across our diverse portfolio while expanding our business geographically. Despite the challenges introduced by COVID-19, we executed effectively in Q2, growing year-over-year global revenues by 6% with 13% from volume. Our U.S. business grew 7% with 14% from volume, and our ex-U.S. business grew volume by 11%, posting nearly $1.5 billion in sales.

Despite the challenges introduced by Cobot 19, we executed effectively in Q2 growing year over year global revenues by 6% with 13% from volume.

Our U.S. business grew 7% with 14% from volume and our X U.S. business grew volume by 11% posting nearly $1.5 billion in sales.

Murdo: As expected, during Q2, we experienced varying degrees of impact from COVID-19 across our portfolio. In exiting Q1 and through the first part of Q2, we saw interruptions to physician-patient interactions that led to delays in diagnosis and treatment. During the quarter, certain professional medical societies, such as NCCN and others, introduced treatment guidelines to assist in decision making during the pandemic. Implementation of those guidelines had varying degrees of impact on prescribing for some of our products. For example, Prolia, which addresses an older, more vulnerable patient population and requires in-office administration, experienced greater negative impact early in the course of the trial.

As expected during Q2, we experienced varying degrees of impact from covert 19 across our portfolio.

Exiting Q1 and through the first part of Q2, we saw interruptions to see physician patient interactions the led to delays in diagnosis and treatment.

During the quarter certain professional medical societies, such as NCCN and others introduced treatment guidelines to assist in decision, making during the pandemic implementation of those guidelines had varying degrees of impact on prescribing for some of our products.

For example, Prolia, which addresses an older more vulnerable patient population and requires in office administration.

We experienced greater negative impact early in the course or.

Murdo: In the case of end plate, we saw a transition to competing oral alternatives as patients looked to limit their visits to doctor's offices. Xgeva was also impacted by fewer patient visits and NCCN's recent recommendation to prioritize primary cancer treatments over bone-targeting agents. In contrast, NUELASTA OMPRO benefited during the quarter.

In the case event plate, we saw transition to competing oral utterances as patient slipped to limit their visits to doctors offices.

X Chiba was also impacted by fewer patient visits and NCCN. His recent recommendation to prioritize primary cancer treatments over bone targeting agents.

In contrast, neulasta onpro benefited during the quarter.

Murdo: As physicians and patients learned more about ways to reduce the risk of COVID infections and as local conditions improved in many countries and states, we saw some recovery during the second half of the quarter. Let me just spend a few minutes discussing steps we've taken to provide continuity of care for patients during the pandemic. In Bone Health with Prolia, we implemented programs to address issues such as identifying alternate sites of care, mobile nurse-administered injections, and prescription fills at specialty and retail pharmacies.

As it provides a convenient solution to help patients deployed additional visits to their site of care post chemotherapy.

As physicians and patients learned more about ways to reduce the risk of cobot infections and as local conditions improved in many countries and stage. We saw some recovery during the second half of the quarter.

Let me just spend a few minutes discussing steps we've taken to provide continuity of care for patients during the other pandemic.

In bone health with Prolia, we implemented programs to address issues such as identifying alternate sites of care mobile nurse administered injections and prescription fills that specialty and retail pharmacies.

Murdo: Given Prolea's six-month dosing schedule, we're keeping a close eye on further disruptions to the balance of 2020 and into 2021. For Avenity, we continue to see this product as a complementary growth opportunity with its unique bone building profile and usage in high-risk post-fracture patients. Within cardiovascular, total Repatha prescriptions grew quarter over quarter, in part because of access and affordability improvements. We experienced a reduction in new prescriptions in April due to COVID-19, but we saw improvements later in the quarter. While we're pleased with the new patient growth in Repatha, we're disappointed by CVS's decision to remove Repatha from its national formulary as of July 1st, which will negatively impact total prescription growth in the third quarter. However, even with this formulary change, we continue to have segment-leading coverage in the PCSK9 class with 75% of lives covered.

Given prolia six month dosing schedule, we're keeping a close eye on further disruptions for the balance of 2020 and into 2021.

With that entity, we continued to see this product as a complimentary growth opportunity with its unique blend building profile and usage in high risk post fracture patients.

Within cardiovascular total repatha prescriptions grew quarter over quarter.

In part because of access and affordability improvements.

We experienced the reduction in new prescriptions in April due to cope with 19, but saw improvements later in the quarter.

While we're pleased with the new patient growth in Repatha, we're disappointed by CBS his decision to remove repatha permits national formulary as of July 1st which will negatively impact total prescription growth in the third quarter.

However, even with this formulary change we continued to have segment leading coverage in the P.C.S. canine class with 75% of lives covered.

Murdo: And given the significant unmet medical need for treating high-risk cardiovascular patients, we remain very confident in our ability to grow RIPAP. Moving to our inflammation portfolio, Tesla TRX growth remains strong in the quarter. Well, Tesla grew and new to brand prescriptions and maintained a leading NBRX share, despite a decline in NBRX volume for the overall psoriasis market due to COVID-19. Additionally, Tesla has proved to be a convenient option for patients due in part to its oral administration and lack of required lab monitoring. Well, Tesla's performance is tracking ahead of our original expectations, in part due to exceptional integration. However, with Enbrel, the pace of growth in the RA market slowed this quarter, causing a greater decline in overall market unit volume than past quarters.

And given the significant unmet medical need in treating high risk cardiovascular patients, we remain very confident in our ability to grow or though.

Moving to our inflammation portfolio with Tesla Trx growth remained strong in the quarter, what Tesla grew in new to brand prescriptions and maintained a leading and be Rx year. Despite a decline and then be Rx volume for the overall psoriasis market due to cold, but 19.

Well Tesla has proved to be a convenient option for patients due in part to its oral administration and Wackos required lab monitoring.

Well Tesla performance is tracking ahead of our original expectations in part due to exceptional integration.

Within Brazil, the pace of growth and they are aid market slowed this quarter, causing a greater decline in overall market unit volume than in past quarters consistent with prior results, we anticipate volume and that tripe net price trends for Enbrel to continue through Twentytwenty.

Murdo: Consistent with prior results, we anticipate volume and net price trends for Enbrel to continue through 2020. Enbrel is the cornerstone of our inflammation therapeutic area, behind which we continue to invest, especially given the reaffirmation of Enbrel's intellectual property. We also continue to find promotional synergies across our inflammation portfolio of Otezla, Enbrel, Amgevita, and recently launched Avsola, our biosimilar to infliximab. Moving to our biosimilar products, they generated $357 million in sales in Q2. As a reminder, these products are promoted by the same teams as our branded products, making for an efficient commercial model. As we talk with customers, they increasingly recognize the value proposition of Amgen's biosimilars, given their high quality, reliable supply, and cost savings they provide. In late Q1 and early Q2, social distancing measures also led to medical distancing. Looking ahead, we see a different pattern in the second half of 2020.

Ambarella is a cornerstone of our inflammation therapeutic area behind which we continue to invest especially given the reaffirmation of umbrellas intellectual property.

We also continue to think promotional synergies across our inflammation portfolio, although Tesla and barrel I'm, just heater and recently launched I've Sola, our biosimilar to flex or not.

Moving to our Biosimilar products, they generated $357 million in sales in Q2 as a reminder, these products are promoted by the same teams as our branded products, making clear inefficient commercial model.

As we talk with customers increasingly recognized the value proposition of amgen's bio similars, given their high quality reliable supply and cost savings they provide.

In late Q1 in early Q2, social distancing measures also led to medical distancing looking ahead, we see a different path or and then the second half of Twentytwenty.

Murdo: While social distancing remains a critical behavior to minimize the risk of COVID infection, providers and payers are encouraging patients to stay in touch with their doctors and to continue to seek medical care, either by telemedicine or through in-person appointments. While certain parts of the U.S. and other countries have observed an increase in COVID-19 infections, our conversation with customers indicates that they are better prepared to handle spikes in cases as compared to four months ago. We continue to be vigilant and watch the spread of the virus, as additional patient care disruptions could occur. I am very appreciative of the hard work of Amgen employees through these challenging times. We remain focused on ensuring continuity of care for patients, including executing on investments in the second half of 2020 to drive growth in our markets for products, continue our geographic expansion, and prepare for potential new product launches. And with that, I'll turn it over to Dave Reese.

While social distancing remains a critical behavior to minimize the risk of cold infection, we see providers and payers encouraging patients to stay in touch with adult theirs and to continue to seek medical care.

Hi, there by telemedicine or through in person appointments.

While certain parts of the U.S. and other countries have observed an increase in cold and 19 its actions our conversation with customers indicates that they are better prepared to handle spikes in cases.

As compared to four months ago.

We continue to be vigilant and watch the spread to the virus as additional patient care disruptions could occur.

I'm very appreciative of the hard work with Amgen employees through these challenging times.

We remain focused on ensuring continuity of care for patients, including executing on investments in the second half with 2020 to drive growth of our marketed products continue our geographic expansion and prepare for potential new product launches and with that I'll turn it over to decrease.

Thanks, Murdo good afternoon, everyone.

David M. Reese: Thanks, Murdo. Good afternoon, everyone.

David M. Reese: I'll begin with an update on our clinical trial execution as we look forward to important data sets in the second half of 2020, enrollment in our clinical studies has rebounded in recent weeks, and we have resumed enrollment in most of the studies that we paused due to COVID-19. Going forward, we expect to make additional investments in the second half of the year, as enrollment increases in our clinical studies and work in our research labs approaches pre-COVID levels. We're also putting in place strategies to mitigate the uncertainties in clinical research created by any potential regional outbreaks of COVID-19.

I'll begin with an update on our clinical trial execution as we look forward to important data sets the second half of 2020.

Enrollment in our clinical studies has rebounded in recent weeks, we have resumed enrollment to most of the studies that we paused due to cope with 19 going forward, we expect to make additional investments in the second half a year as enrollment increases in our clinical studies you know to work in our research labs approaches pre covance levels.

We also putting in place strategies to mitigate the uncertainties and clinical research created by any potential regional outbreaks of covert 19.

David M. Reese: Importantly, our pivotal studies for sodoracib, tezapelumab, and omacamptib-micarbol remain on track, and we continue to expect high-quality data sets from these trials later in the year. We have also initiated new trials, including the Sotoracib Phase III lung cancer study and several Sotoracib Phase I combination cohorts. Finally, we continue to make progress with our Half-Life Extended Bite programs and, as previously communicated, anticipate sharing initial data for AMG-701 targeting BCMA and AMG-757 targeting DLL-3 at meetings in the second half of 2020. Additionally, initial data from the AMG 160 program targeting prostate-specific membrane antigen, or PSMA, will be presented at the virtual ESMO meeting in September. We will be presenting an update on our sodoracid phase one non-small cell lung cancer cohort, including initial biomarker data, at ESMO as well.

Importantly, our pivotal studies for sort of Rassam tend to tell you map Endomechanical mecarbil remain on track and we continue to expect high quality datasets from these trials later in the year.

We've also initiated new trials, including the soda Rassam phase three lung cancer study in several sator acid phase one combination cohorts. Finally, we continue to make progress with our half life extended bite programs and as previously communicated anticipate sharing the initial data for AMG seven or one.

Targeting bcm may empty 757 targeting PLM three didn't meetings in the second half of 2020.

Initial data from the MG 160 program targeting prostate specific membrane antigen or PS I may well complete will be presented at the virtual ESMO meeting in September.

We will be presenting an update on our soda rassam phase one non small cell lung cancer cohort, including initial biomarker data at ESMO as well.

In our mid stage pipeline based on encouraging phase one data in patients with elevated LP little a AMG 890 or short interfering as our M&A or that's IR Nay has now entered phase two development.

David M. Reese: In our mid-stage pipeline, based on encouraging Phase I data in patients with elevated LP a, AMG 890, our short-interfering RNA, or siRNA, has now entered Phase II development for inflammation. With AstraZeneca, we made a strategic decision to discontinue the Phase 2 trial of tezapelimab in atopic dermatitis after reviewing the 16-week top-line data. No new safety signals were observed, and this decision has no impact on the ongoing studies in asthma and COPD.

In inflammation.

With Astra Zeneca, we made a strategic decision to discontinue the phase two trial in terms of telling him out in atopic dermatitis. After reviewing the 16 week topline data no new safety signals were observed and this decision has no impact on the ongoing studies in asthma and C O PD.

Let me conclude by saying a few words about her efforts against Cobot 19.

David M. Reese: Let me conclude by saying a few words about our efforts against COVID-19. We are investigating OTESLA in multiple platform trials as a potential immunomodulatory treatment in patients hospitalized with a viral infection, and the first of these studies should be announced in the coming days. In our pursuit of therapeutic antibodies, we are taking an orthogonal approach by focusing our efforts on the development of antibodies against targets other than the SARS-CoV-2 receptor binding domain, the RBD, the goal here being to develop an antibody complementary to the first-generation therapy.

We are investigating otezla and multiple platform trials as a potential immunomodulatory treatment in patients hospitalized with viral infection in the first of these studies should be announced in the coming days.

In our pursuit pursuit of therapeutic antibodies, we are taking orthogonal approach by four focusing our efforts on the development of antibodies against targets other than the Sars Kofi to receptor binding domain. The our BD the goal here being to develop an antibody complimentary to the first generation therapy.

I'll be happy to discuss the or any other topics further in the queue in a session.

David M. Reese: I'll be happy to discuss these or any other topics further in the Q&A session. Before I hand off to Peter, I'd like to thank all of our staff for continuing to deliver care for patients during a difficult and important time.

Sure I hand off to Peter I'd like to thank all of our staff for continuing to deliver for patients during a difficult and important time Peter.

Thank you Dave good afternoon.

I hope everyone is healthy and safe.

Let's turn to the business.

Our confidence in the growth potential of our business remains strong.

This is exemplified by our solid execution in the second quarter.

You will find our detailed Q2 results in the press release.

Peter: Thank you, Dave. Good afternoon. I hope everyone is healthy and safe. Now, let's turn to the business. Our confidence in the growth potential of our business remains strong, as this is exemplified by our solid execution in the second quarter. You will find our detailed Q2 results in the press release. Now, let me provide some summary comments on how I view the quarter on a year-over-year basis. We delivered 6% revenue growth and 7% non-GAAP EPS growth during the second quarter in a challenging environment. We are particularly pleased with revenue growth, driven largely by unit volume increases in Otesla, biosimilars, Avenity, and Repap. Operating expenses increased 2% year-over-year as we continue to invest to drive growth, while recognizing COVID-19 related expense slowdowns. These slowdowns were pronounced in the second quarter, including a slowing of clinical trial activity. However, we exited the second quarter with an acceleration of activity as most trials were initiating clinical sites and enrolling patients.

Let me provide some summary comments on how I view the quarter.

On a year over year basis, we delivered 6% revenue growth and 7% non-GAAP EPS growth during the second quarter.

In a challenging environment.

We're particularly pleased with revenue growth driven largely by unit volume increases in Otezla bio similars of entity and Repatha.

Operating expenses increased 2% year over year as we continue to invest to drive growth, while recognizing cobot 19 related expense slowdown.

These slowdowns were pronounced in the second quarter, including a slowing of clinical trial activity.

However, we exited the second quarter with an acceleration of activity as most trials were initiating clinical sites in enrolling patients.

Overall, we expect to increased investment in the second half of the year.

We have a strong balance sheet and cash position.

Disposition was further strengthened in the second quarter with free cash flow of 2.7 billion and our debt issuance of 4 billion at attractive rates.

Our capital allocation principles and plans remain unchanged and uninterrupted.

Investment in both internal and external innovation remains the cornerstone of our long term growth.

Peter: Overall, we expect to increase investment in the second half of the year. We have a strong balance sheet and cash position. This position was further strengthened in the second quarter with free cash flow of $2.7 billion and our debt issuance of $4 billion at attractive rates. Our capital allocation principles and plans remain unchanged and uninterrupted. Investment in both internal and external innovation remains the cornerstone of our long-term growth. Earlier this month, we announced an additional $421 million in investment in Beijing, reflecting our confidence in our ongoing collaboration with them. Further underscoring our confidence in generating free cash flow, we continue to return capital to shareholders through both growing dividends and opportunistic share repurchase. Let me now share some thoughts on our outlook going forward. We experienced a negative impact from COVID-19 on our sales early in the second quarter but began to see a general recovery in the second half of the quarter.

Earlier this month, we announced an additional $421 million of investment in Beijing.

Reflecting our confidence in our ongoing collaboration with them.

Further underscoring our confidence in generating free cash flow, we continue to return capital to shareholders through both growing dividends and opportunistic share repurchases.

Let me now share some thoughts on our outlook going forward.

We experienced the negative impact from Cobot 19 on our sales early in the second quarter, but began to see a general recovery in the second half of the quarter.

The more recent resurgence of covert 19 infections in parts of the United States and certain other country create significant uncertainty both in the magnitude and the specific timing of the recovery.

This could cause fluctuations in our quarterly revenues and earnings over the duration of the pandemic.

Despite this uncertainty we are reaffirming our revenue guidance of 25.0 billion to 25.6 billion.

We are updating our non-GAAP earnings per share guidance to $15, a 10 cents to $15, a 75 cents versus prior guidance at $14, an 85 cents.

$15.60.

This reflects our confidence in our underlying business continuing to deliver for patients.

For the full year, we continue to expect total non-GAAP operating expenses to grow in the high single digit percentage range year over year with a breakdown as follows.

Peter: The more recent resurgence of COVID-19 infections in parts of the United States and certain other countries creates significant uncertainty both in the magnitude and the specific timing of the recovery. This could cause fluctuations in our quarterly revenues and earnings over the duration of the pandemic. Despite this uncertainty, we are reaffirming our revenue guidance of $25.0 billion to $25.6. We are updating our non-GAAP earnings per share guidance to $15.10 to $15.75, versus prior guidance of $14.85 to $15.60. This reflects our confidence in our underlying business continuing to deliver for patients. For the full year, we continue to expect total non-GAAP operating expenses to grow in the high single-digit percentage range year-over-year, with a breakdown as follows. Cost of sales is the percent of product sales to be generally consistent with 2019.

Cost of sales as a percent of product sales to be generally consistent with 2019.

In R&D, we plan to increase investments in the second half of the year, including in our innovative pipeline.

And as clinical trial and lab activity accelerate.

FG and H spend is projected to increase primarily due to low Tesla geographic expansion and launch preparations for our late stage pipeline.

I would re emphasize that we expect operating expenses to meaningfully increase in the second half of the year as the recovery continues.

This increase reflects first investments in our pipeline as well as launch preparation.

And secondly, the typical historical spend pattern for our business.

We anticipate non gap other income and expense to be a net expense of about 1.4 billion.

We continue to expect share repurchases at an amount at the lower end of our previously disclosed range of $3 billion to $5 billion.

And I too would like to thank all of my colleagues around the world for their commitment to the Amgen difference the patient.

This concludes the financial update I'll turn it back the Bob to get to our Q in it.

Hi, Eric can you remind our callers other procedures for.

In their questions.

Yes, as a reminder to ask a question you need a press star one on your telephone Gillam draw. Your question press the pound key please standby <unk> day roster.

Peter: In R&D, we plan to increase investments in the second half of the year, including in our innovative pipeline and as clinical trial and lab activity accelerates. SG&A spend is projected to increase primarily due to a Tesla, geographic expansion, and launch preparations for our late-stage pipeline. I would re-emphasize that we expect operating expenses to meaningfully increase in the second half of the year as the recovery continues. This increase reflects, first, investments in our pipeline as well as launch preparations, and secondly, the typical historical spend pattern for our business. We anticipate non-GAAP other income and expense to be a net expense of about $1.4 billion. We continue to expect share repurchases at an amount at the lower end of our previously disclosed range of $3 to $5 billion. And I, too, would like to thank all of my colleagues around the world for their commitment to making the Amgen difference for patients. This concludes the financial update. I'll turn it back to Bob to get to our Q&A.

And your first question is from.

With credit Suisse.

Hi, guys. Thank you so much for taking the questions I appreciate the no format of the call. So I'm looking at.

Curious on the TESTOPEL you may have phase two atopic dermatitis data did you see any signal in this trial and more importantly is there any read through to the phase three aspect trial expected later this year.

Hi, Thanks, Evan this is Dave I'll take that question.

While there was some evidence of activity on some disease measures. We just have topline data right now we've got a number of additional analyses, including biomarker analyses to do.

Importantly, I really don't think theres much read through it all to asthma and in fact, the best insights we have into the activity of the drug in asthma or the large phase two study that we previously conducted in asthma across the range of patients with both isn't to fill high and it's going to fill low all forms of the.

Disease, and we're on track as I mentioned for the read out of those data.

In this doesn't really change our point of view on asthma.

Okay, great. Thank you.

Your next question is from Werber with Cowen.

Operator: Okay, Erica, can you remind our callers of the procedures for asking their questions?

Great. Thanks for taking my question I thought maybe a quick question on Biosimilars and again, you're continuing to really capture a lot of share your sort of in the third use already with the bassi in conjunction with.

Operator: Yes, as a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. And your first question is from Evan Seigerman with Credit Suisse.

You had some destocking and now it sounds like you're obviously or continue to expect some competition coming in so I want to know give us a sense kind of if you can where are you sitting with inventories and and how much competition or how impactful, but competition do you think will be given that you're capturing share and how quickly would have sold off.

Evan Seigerman: Hi guys, thank you so much for taking the questions, and I appreciate the new format of the call. So, I'm looking at the data from the Tess Pelemev phase 2 atopic dermatitis trial. Did you see any signal in this trial? And more importantly, is there any read-through to the phase 3 asthma trial expected later this year?

Really be a meaningful contributor thank you.

Yeah, Thanks, your own Netsmart, though.

We are very pleased with the performance of the Biosimilar portfolio and specifically the to the you highlighted embassy and can GNC, which quite frankly in the period of time, that's been disrupted by cold, but I think providers are looking for a lot of places where they can extract more value in the healthcare since.

Dave: Thanks, Evan. This is Dave.

Dave: I'll take that question. You know, while there was some evidence of activity on some disease measures, we just have top-line data right now. You know, we've got a number of additional analyses, including biomarker analyses, to do. But importantly, I really don't think there's much read-through at all to asthma. And, in fact, the best insights that we have into the activity of the drug in asthma are the large Phase II study that we previously conducted in asthma across the range of patients with both eosinophil high and eosinophil low forms of the disease. So, you know, we're on track, as I mentioned, for the readout of those data. And this doesn't really change our point of view on asthma.

So we've been pleased with the uptake or as you mentioned, we're in the high Thirtys within Basi mid Thirtys with can GNC and we don't see those trends swelling.

Right now given competition. So that's the first comment I would make an overall inventories there's been no real build there over the last few weeks. So we continue to see a normal inventory levels at the bio similars market.

I would stick to your point on competitive dynamics overall as more entrants come into the market I would say were less challenged on share, but you might see something that price effects of multiple competitors entering.

Dave: Okay, great. Thank you.

Yaron Werber: Your next question is from Yaron Werber with Cowan.

Yaron Werber: Great. Thanks for taking my question. I have maybe a quick question on biosimilars. And again, you continue to

Or do you want to touch on absolute which was one of your other questions you're on us.

Yaron Werber: to really capture a lot of share. You're sort of in the 30s already with Ambassi and Congenti. You've had some de-stocking, and now it sounds like you obviously are continuing to expect some competition coming in. So I want to know, give us a sense, kind of, if you can, where you are sitting with inventories and how much competition or how impactful of a competition do you think will be given that you're capturing share, and how quickly would Apsola really be a meaningful contributor? Thank you.

Oh, thanks for that prompt Bob Yes, where.

We're pleased we just recently launched Sola at the beginning of July our bio similar to Infliximab. It's early days. So I don't really have any performance metrics to to provide with you.

It is a nice addition to our strong.

Inflammation portfolio with and Brazil, Otezla upsell and soon or some other biosimilar as well as hopefully TESTOPEL you Matt So.

Really strengthening our portfolio overall, we are a little later on this one so we're going to see how do we do in the market versus the existing competitors, but.

Murdo: Yeah, thanks Yaron, it's Murdo. We are very pleased with the performance of the Biosimilar portfolio and specifically the two that you highlighted, Embasi and Kanjinti, which, quite frankly, in the period of time that's been disrupted by COVID, I think providers are looking for a lot of places where they can extract more value from the healthcare system. So we've been pleased with the uptake. As you mentioned, we're in the high 30s with Embasi, and mid 30s with Kanjinti, and we don't see those trends rising right now given competition. So that's the first comment I would make.

We have a strong team there and just like we did with oncology, where we use our innovative field force who have existing relationships with providers.

To commercialize our Biosimilar is they're doing the same thing and inflammation.

Erica that's taking your question please.

Your next question is from Jay Olson with Oppenheimer.

Oh, hi, Thanks for taking my question and congratulations on an impressive quarter during difficult times.

I'm curious about the comments you made regarding mobile administration of Prolia.

Is that a temporary strategy to navigate the pandemic or is it something you consider more of a permanent arrangement and if so would you also consider providing home infusion for other Andrew other Amgen drugs. Besides prolia.

Murdo: And overall inventories, there's been no real build there over the last few weeks. So we continue to see normal inventory levels in the biosimilars market. I would say to your point on competitive dynamics overall, as more entrants come into the market, I would say we're less challenged for share, but you might see some net price effects of multiple competitors entering.

Thanks for the question Jay.

Yeah. The Prolia story is one that I'm really thankful for that team mobilize very quickly around the world wasn't just in the U.S. Prolia is in many markets actually a hospital administer products and you know if I can use in Italy. As an example, we actually were able to do home delivery of Prolia for Italian patients.

Murdo: Murdo, do you want to touch on Absolo, which was one of the other questions Yaron asked?

If you recall is the spike that they had with Covidien northern Italy in the U.S., we worked closely actually with CMS and and even the F.D.A. to ensure that.

Murdo: Thanks for the prompt reply, Bob. Yes, we're pleased. We just recently launched Avsola at the beginning of July, our biosimilar to infliximab. It's early days, so I don't really have any performance metrics to provide for you. It is a nice addition to our strong inflammation portfolio with Enbrel, Otezla, Avsola and soon some other biosimilars as well as, hopefully, Tezapelimab. So, really strengthening our portfolio overall. We are a little late on this one, so we're going to see how we do in the market versus the existing competitors, but we have a strong team there.

We were appropriately opening up alternate sites of care for Prolia patients and we were successful in securing this mobile nurse platform that you alluded to we also actually opened up the possibility of.

Home infusion or injection in this case with Prolia.

And potentially even self administration, we developed a within put from the FDA self administration kit.

I would say this way I'd say the vast majority of Prolia administrations is still are still in office and continued to be as long as we have relatively open access to physician practices and physician sub evolved and our adapting to covert by helping create safe waiting rooms and safe.

Bob: Erica, let's take the next question.

Operator: Your next question is from Jay Olson with Oppenheimer.

Jay Olson: Oh, hi. Thanks for taking my question. And congratulations on an impressive quarter during difficult times.

Jay Olson: I'm curious about the comments you made regarding mobile administration of Prolia. Is that a temporary strategy to navigate the pandemic, or is that something you consider more of a permanent arrangement? And if so, would you also consider providing home infusions for other Amgen drugs besides Prolia?

Care environment for patients, however, should there be or additional spikes in coal that or additional disruption to that patient care. We believe we've opened up other channels that we feel good about in helping patients have continuity of care.

Murdo: Thanks for the question, Jay. You know, the Prolia story is one that I'm really thankful for. That team mobilized very quickly around the world; it wasn't just in the US. Prolia is in many markets, actually a hospital administered product. And, you know, if I can use Italy as an example, we actually were able to do home delivery of Prolia for Italian patients, if you recall the spike that they had with COVID in northern Italy. In the US, we worked closely with CMS.

As to the long term possibility of this I think look we see a lot of innovations during coded that could persist.

There are definitely some reimbursement mechanisms.

Probably a being a part b product that make that a little more difficult, but with time, a an experience we'll know more on how to continue to make <unk> prolia available to patients.

Thank you.

Your next question is from parents.

Goldman Sachs.

Hi, great. Thanks for taking the question.

It was just wondering if you think about your bite platform here is your confidence level in the platform. The same in terms of the heme indications versus the solid tumor indications just wanted to kind of get a sense from your I know you've made some comments in them before about solid tumor activity, but just curious on kind of how you view that lately and then can you just remind us of that.

Murdo: And even the FDA to ensure that we were appropriately opening up alternate sites of care for Prolia patients. And we were successful in securing this mobile nurse platform that you alluded to. We also actually opened up the possibility of home infusion or injection, in this case, with Prolia, and potentially even self-administration. We developed, with input from the FDA, a self-administration kit. I would say this way:

Design of the 160 phase one study you that's going to be at ESMO, and maybe what your I'm, hoping to see to advance into phase two thank you.

Oh, yeah. Thanks for the question.

Murdo: I would say the vast majority of Prolia administrations are still in office and will continue to be as long as we have relatively open access to physician practices. And physicians have evolved and are adapting to COVID by helping create safe waiting rooms and safe care environments for patients. However, should there be additional spikes in COVID or additional disruption to patient care, we believe we've opened up other channels that we feel good about helping patients have continuity of care. And as to the long-term possibility of this, I think, look, we see a lot of innovations during COVID that could persist. There are definitely some reimbursement mechanisms with Prolia being a Part B product that make that a little more difficult. But with time and experience, we'll know more about how to continue to make Prolia available to patients. Thank you.

As I mentioned, we're going to be presenting at ESMO. The Onesixty data you know we've got.

Two of the bite programs moving along in solid tumors out one and the program targeting CLL three in small cell lung cancer. Both of those are in dose escalation, so you're going to see our the initial dose escalation from 160 at ESMO, you know I would say.

We're seeing you know interesting hints of activity you know you'll get to look at those data.

As we move forward, it's still early days and we're still dirt dose ranging.

I think we remain confident in the half life extended bite platform and we're looking forward to pushing those studies through dose escalation.

Your next question Geoff Meacham with Bank of America.

Hey, guys. Thanks for taking the question.

Bob I want to get your thoughts on the drug pricing in other executive orders I didn't hear much about it.

The prepared remarks, and so the question here would you expect.

Unknown Attendee: Your next question is from Karen Flynn with Goldman Sachs.

Implementation its current form an answer as written.

David M. Reese: Hi, great. Thanks for taking the time to answer the question. Dave, I was just wondering, as you think about your BITE platform here, is your confidence level in the platform the same in terms of the heme indications versus the solid tumor indications? I just wanted to kind of get a sense from you. I know you've made some comments before about solid tumor activity, but just curious about kind of how you view that lately. And then can you just remind us of the design of the 160 Phase I study that's going to be at ESMO and maybe what you're hoping to see there? As we do advance into Phase II, thank you.

Where would you imagine a would be the grid as exposure relative to the Amgen portfolio. Thank you.

Oh, Jeff I'd, just say, it's early days still a word.

We're seeing the actual language behind these executive orders and we're pleased that one of the executive orders addresses the rebate mechanism and we're very focused on as you know our view is a nation needs more innovation not less and the nation. These have less innovations getting stuck on pharmacy shelves or make.

Yes, when patients and one way to do those to try to bring down now pocket cost for particular seniors up the pharmacy and we think the rebate rules executive orders, we understand it anyway opens the door for for that so that feels construction, obviously, there's a lot of focus as well Jeff on this.

David M. Reese: Yeah, thanks for the question. You know, as I mentioned, we're going to be presenting the 160 data at ESMO. We've got two of the BITE programs moving along in solid tumors, that one and the program targeting DLL-3 in small cell lung cancer. Both of those are in dose escalation, so you're going to see the initial dose escalation from 160 ad esmo. You know, I would say, you know, we're seeing, you know, interesting hints of activity. You know, you'll get a look at those data as we move forward. It's still early days, and we're still dose ranging. But, you know, I think we remain confident in the Half-Life Extended BITE platform, and we're looking forward to pushing those studies through dose escalation.

Well shaver nation, or Ipi like executive order, but.

As far as I'm aware of the language on that is not available yet.

Obviously.

For us and I think for all the innovators in our industry. The idea of importing prices socialized medicine countries, where they're all kinds of other excess.

Problems for innovative medicines like.

Like ours, Unlike those which you know citizens bank system, we think is problematic and the good news for.

Seniors in United States is virtually all the innovated cancer medicine.

Ask us about and that we're so excited about are available to our citizens.

Very different picture in other parts of the world, putting other parts and we're also that.

Geoff Meacham: Your next question is from Geoff Meacham with Bank of America.

The federal on my reference so.

Geoff Meacham: Hey guys, thanks for taking the question. Bob, I want to get your thoughts on drug pricing and other executive orders. I didn't hear much about it in the prepared remarks. And so the question is, you know, what would you expect?

We will watch you know.

Churn, but we think they're better ways to address the issue them.

And that ish.

Approach. So thank you I'm sure we'll be more information on it as time passes.

Okay. Thank you.

Your next question is from Chris Raymond with Piper Sandler.

Hey, Thank you just with regard to aim of big some part checks. We've done recently, a indicate theres a pretty decent level of receptivity to oral ctr piece and the prevention setting once some once those options are labeled.

Bob: Thank you.

Bob: Jeff, I would just say it's early days still, you know; we're looking forward to seeing the actual language behind these executive orders. And we're pleased that one of the executive orders addresses the rebate mechanism. And we're very focused on, as you know, our view is that the nation needs more innovation, not less. And the nation needs less innovation sitting on pharmacy shelves and making its way to patients. And one way to do that is to try to bring down the out-of-pocket cost for, in particular, seniors at the pharmacy. And we think the rebate rule, the executive order, as we understand it anyway, opens the door to that. So that feels constructive.

Maybe a murdo, maybe just sort of talking about your view of the sort of the longevity of Subcu seats. Your piece in general and maybe Im a big in particular.

Even when when there's an oral option available in that setting. Thanks.

Thanks, a question Chris Yes. The overall, we have to just reflect on the huge unmet need with migrating here.

We are barely penetrating roughly a 4 million.

Incident patient population, where there's a significant amount.

Bob: You know, obviously, there's a lot of focus as well, Jeff, on this most favored nation or IPI-like executive order. But as far as I'm aware, the language on that is not available yet. And, you know, obviously, for us, and I think for all the innovators in our industry, the idea of importing prices from socialized medicine countries, where there are all kinds of other access problems for innovative medicines like, like ours, and like those which US citizens have access to, is problematic. And the good news for seniors in the United States is that virtually all the innovative cancer medicines that you asked us about and that we're so excited about are available to our And it's a very different picture in other parts of the world, including other parts of the world that that, that that order might reference. So we will watch with, you know, concern, but we think there are better ways to address the issue than that approach. So stay tuned. I'm sure there'll be more information on it as time passes.

Medications that just do not provide the migraine relief that theme as a big.

Ken So far we're pleased with the evolution of penetrating that unmet need with them as they again, where we're definitely very pleased with the impact we've had on patients' lives. What we're seeing so far with the oral agents is really they're used more as an add on.

Ah treatment options given their current indications and I think that's actually helping further strengthen aim as a igs perception in clinical experience for patients from the Raul just it'll be interesting to see what the data look like on the prevention side and what a labor.

During looks like as well, but overall I think there's a lot of room for.

More patients to benefit from a C geography based therapy, and we think we've got.

The one of the best if not the best given the convenient once a month injection the really strong coverage that we now have across the U.S. in terms of insured benefit and great patient support programming to help patients.

Bob: Okay, thank you.

Christopher Joseph Raymond: Your next question is from Chris Raymond with Piper Sandler.

Christopher Joseph Raymond: Hey, thank you. Just with regard to Amavig, some of the checks we've done recently indicate there's a pretty decent level of receptivity to oral CGRPs in the prevention setting once those options are labeled. Maybe, Murdo, maybe just sort of talk about your view of the sort of longevity of sub-QCGRPs in general and maybe aim-a-vig in particular, you know, even when there's an oral option available in that setting.

Possibly even tie trade up in their dosing on name a big So I think a lot of a lot of growth yet to be realized even with additional entrance in the market.

Thank you very much.

Yeah. This is Dave. This is Chris. This is Dave you know I would just add that obviously, we'll be looking I thought you know long term safety.

With the small molecules when you get to chronic administration and when you were very happy with the long term safety profile now extending your for four years in some patients with him as big.

Murdo: Thanks for the question, Chris. Yeah, overall, we have to just reflect on the huge unmet need for migraine here. You know, we are barely penetrating roughly a 4 million incident patient population where there's a significant amount of medications that just do not provide the migraine relief that Amavig can. And so far, we're pleased with the evolution of penetrating that unmet need with Amavig, and we're definitely very pleased with the impact we've had on patients' lives. What we're seeing so far with the oral agents is that they are really used more as add-on treatment options given their current indications, and I think that's actually helping further strengthen Amavig's perception in clinical experience for patients from neurologists. It'll be interesting to see what the data look like on the prevention side and what labeling looks like as well.

Your next question is from a Ronny Gal Bernstein.

Good morning.

For David first if you don't my clarifying you kind of mentioned if there's a belknap data in atopic dermatitis, you haven't mentioned safety side you know.

In the phase two and asked when you did it Julian board and it gets stronger and there's always a considerable success and there's population I was wondering you could just clarify if we're seeing this signaled repeating themselves.

In the EMEA atopic dermatitis style.

And then on the neutralizing antibody strategy is the strategy that you have you can find antibodies, which are complimentary to the spike proteins on that coming instead of the people strategy was to look for them. The high specificity antibody or is this an addition additional strategy.

Murdo: But overall, I think there's a lot of room for more patients to benefit from a CGR-based therapy, and we think we've got one of the best, if not the best, given the convenient once-a-month injection, the really strong coverage that we now have across the U.S. in terms of insured benefits and great patient support programming to help patients possibly even titrate up in their dosing on Amavig. So I think a lot of growth is yet to be realized even with additional entrance into the market. Thank you very much.

Yeah. Thanks Ronny.

So.

Oh, you know in regard to the TV data you know I would say there were no concerning safety signals at all in the phase two a topic dermatitis.

Trial the phase three trial as is standard has an independent data monitoring committee that of course periodically evaluate safety and.

I have always indicated the trial should proceed as planned and all you know we fully expect that that will happen to completion over the coming few months.

Yes in terms of our cobot 19 therapeutic antibody strategy.

David M. Reese: Yeah, this is David. Chris, this is Dave.

You know, we as we have looked at the rapid evolution of the field.

David M. Reese: You know, I would just add that obviously we'll be looking at, you know, long-term safety with the small molecules when you get to chronic administration, and we're very happy with the long-term safety profile now extending, you know, four years in some patients with Amavig.

Most of the antibodies as I'm sure you're aware that have gone into the clinic target the RV de receptor binding domain of despite protein.

Our technical assessment of those antibodies that some of them appear to be quite good.

Unknown Attendee: Your next question is from Ronnie Gale with Bernstein.

And our belief is that we could potentially add value here to the therapeutic armamentarium by developing antibodies targeting a another epitope non overlapping and that could potentially be added to an antibody or a cocktail.

Unknown Attendee: Good morning. The question is for David. First, if you don't mind clarifying, you kind of mentioned that there's PELNAP data on toxic dermatitis, but you haven't mentioned the safety side.

David M. Reese: In the phase 2 anathema, you did see a case of Julian Barr, and I guess Strzok, and there's always a concern for anaphylaxis in this population. I was wondering if you could just clarify if we're seeing this signal repeating itself in the atopic dermatitis trial. And then on the neutralizing antibody strategy, is the strategy that you're having to find in antibodies that are complementary to the spike proteins, is that coming instead of the previous strategy, which was to look for the high-specificity antibody, or is this an additional strategy?

From that first generation. So that is the strategy are we were open to that off from the start and we're now focusing on that I would say as we watch the evolution of the field.

Yeah, it's a shared with US was onto but did you but are you, particularly impressive.

Oh.

I'm not going to comment on now.

Well I'll leave that to us.

[laughter].

Let's take the next question.

Next question is from Matthew Harrison with Morgan Stanley.

Great. Good afternoon. Thanks for taking my question, Dave I was hoping to ask about BRL two new team program.

David M. Reese: Yeah, thanks, Ronnie. So, in regard to the TESI data, I would say there were no concerning safety signals at all in the phase 2 atopic dermatitis trial. You know, the phase 3 trial, as is standard, has an independent data monitoring committee that, of course, periodically evaluates safety, and, you know, they have always indicated the trial should proceed as planned. And, you know, we fully expect that it will happen to completion over the coming few months. You know, in terms of our COVID-19 therapeutic antibody strategy, you know, we, as we have looked at the rapid evolution of the field, most of the antibodies, as I'm sure you're aware, that have gone into the clinic target the RBD, the receptor binding domain of the spike protein.

Seems like you made a decision not to move ahead, but there are obviously sun and GE I indication.

The you. Another companies are studying can you talk a little bit about your excitement or lack thereof around around those other indications and any data you got from Moray, which may influence the profile and there's other indication. Thanks.

Yeah, Matt Thanks for the question.

We remain quite interested in this molecule.

Which again to remind everyone is designed to enhance the number and function of T regulatory cells and restore some of the dysregulation of the him even system that occurs in certain auto immune diseases.

We knew from the start that it's a high bar in rheumatoid arthritis, giving a.

Existing therapies and based on the emerging data elected not to go forward and that indication I think there a variety of other auto immune diseases, where this is of interest and we're continuing to push that program forward as we move towards additional trials of course, we will share that with you and.

David M. Reese: You know, our technical assessment of those antibodies is that some of them appear to be quite good, and our belief is that we could potentially add value here to the therapeutic armamentarium by developing an antibody targeting another epitope, non-overlapping, and that could potentially be added to an antibody or a cocktail from that first generation. So that is the strategy. We were open to that from the start, and we are now focusing on that, I would say, as we've watched the evolution of the trial.

We've got ongoing studies in diseases like lupus aware, there remains significant unmet medical need.

Your next question comes from Michael Yee with Jefferies.

Oh, Hey, there. Thanks for the question a question for David on Omecamtiv Mecarbil question Big fish to be read out and has a unique mechanism inelegant science could you just put into context for us what maybe one or two things you're specifically like from the prior data and what degree of confidence you have given.

David M. Reese: Care to share with us whose antibody you are particularly impressed with?

David M. Reese: You know, I'm not going to comment on that one. I'll leave you to assess the situation.

David M. Reese: Karnani

Operator: Erica, let's take the next question.

Matthew Harrison: Your next question is from Matthew Harrison with Morgan Stanley.

Hi Bar first CV outcomes studied clinical meaningful magnitude of benefit maybe just talk a little bit about that and how you handicap that appreciate it.

David M. Reese: Dave, I was hoping to ask about the IL-2 mutine program. It seems like you made a decision not to move ahead in RA, but there are obviously some GI indications that you and other companies are studying. Can you just talk a little bit about your excitement or lack thereof around those other indications and any data you got from RA which may influence the profile and those other indications? Thanks.

Yes, Thanks, Mike you know as Jim mentioned, there is a it's a novel mechanism action. It's the first drug that directly affects contractility.

Of myocardial cells and that's of course, one of the primary to functions.

In advanced heart failure, so thats, obviously, all priore one of the things that we like about the molecule. In addition, I think the phase two data what you know caught our eye. It was the fact that you know there was internal consistency when you looked across physiological measures the various.

David M. Reese: Matt, thanks for the question. You know, we remain quite interested in this molecule, which, again, to remind everyone, is designed to enhance the number and function of T regulatory cells and restore some of the dysregulation of the immune system that occurs in certain autoimmune diseases. You know, we knew from the start that it's a high bar in rheumatoid arthritis, given existing therapies, and based on the emerging data, elected not to go forward in that indication. But I think there are a variety of other autoimmune diseases where this is of interest, and we're continuing to push that program forward. As we move towards additional trials, of course, we will share that with you, and we've got ongoing studies in diseases like lupus where there remains significant unmet medical need.

Rick.

Outcome measures that are used in mid stage heart failure programs as well as our various biomarkers.

And to see that sort of internal consistency is another thing that gives you confidence, but I would point out that we're now doing the definitive experiment.

Phase three trial in over 8000 patients, it's well powered.

And there will be sufficient follow up on and so I think we're going to know the answer is to the utility of Omecamtiv Mecarbil in advanced heart failure by the end of the here.

Your next question is from Robyn Karnauskas with Suntrust.

Hi, Thanks for taking my question I'd love to do format.

Michael J. Yee: Your next question is from Michael Yee with Jeffreys.

Hi, guys two quick ones what are the trends you're seeing in the doctor's office as far as ease of reimbursement given the economic climate are you having to give more free drug and second question given in barmy talked that spending more in the back half of the year.

Michael J. Yee: Hey there, thanks for the question. Question for David on Omicam to McCarville, of course, a big phase three readout and has a unique mechanism and elegant science. Could you just put in context for us what maybe one or two things you specifically like from the prior data and what degree of confidence you have given a high bar for a CV outcome study, clinically meaningful magnitude of benefit. Maybe just talk a little bit about that and how you handicapped that. I appreciate it.

What about your inc. changes or a new thought.

Your appetite for M&A or business development. Thank you.

Okay, Robin why don't I start with the.

Yeah I'll start with the first part of your question then turn it over to Bob for your second part of your question.

David M. Reese: Yeah, thanks, Mike. You know, as you mentioned, there's a it's a novel mechanism mechanism action. It's the first drug that directly affects contractility of myocardial cells, and that's, of course, one of the primary dysfunctions in advanced heart failure. So that's obviously, a priori, one of the things that we like about the molecule. In addition, I think, you know, the phase two data, what caught our eye was the fact that, you know, there was internal consistency when you looked across physiologic measures, the various physiologic outcome measures that are used in mid-stage heart failure programs, as well as various biomarkers. And to see that sort of internal consistency is another thing that gives you confidence. But I would point out that we're now doing the definitive experiment, you know, a phase three trial in over 8000 patients. It's well powered, and there will be sufficient follow-up. And so, you know, I think we're going to know the answer to the utility of omacamptamacarbo in advanced heart failure by the end of the year.

Overall, we are actually pretty pleased with what we're seeing particularly in the latter part of the second quarter.

In patients accessing reimbursement for their medications.

We do have generous programs that we provide but given the fairly significant expansion in repatha aim of zig.

And then any coverage with a permanent J code, we really have seen less need for those programs.

Currently now that could change in the longer term.

As some of the patients who are maybe currently furloughed could become a displaced or laid off or as patients who may be securing cobra could end up lapsing.

Also many patients end up.

Going off of their own benefits to a sizable benefit so there's multiple layers of how people who are losing their insurance coverage might be able to bridge through different mechanisms were also hopeful and maybe even optimistic that some additional stimulus would be provided so that patients can seek.

David M. Reese: Your next question is from Robyn Karnauskas with SunTrust.

Robyn Kay Shelton Karnauskas: Hi, thanks for taking my question. I love the new format.

Continuity of their healthcare coverage, but.

Robyn Kay Shelton Karnauskas: So I had two quick ones. What are the trends that you're seeing in the doctor's office as far as ease of reimbursement given the economic climate? Are you having to give more free drugs? And second question, given the environmental impact of spending more in the back half of the year, what about your changes or new thoughts, updated thoughts on your appetite for M&A or business development? Thank you.

Overall, I would say so far so good despite significant disruption obviously in our economy.

And on business development Robyn.

I wouldn't point any changes.

Our approach.

Address this I think pretty consistently on prior calls were looking for licensing or acquisition opportunities in the areas our focus so.

We continue.

Her scouring the licensee landscape.

At the moment so.

Murdo: Okay, Robyn, why don't I start with, yeah, I'll start with the first part of your question and turn it over to Bob for the second part of your question. Overall, we're actually pretty pleased with what we're seeing, particularly in the latter part of the second quarter with patients accessing reimbursements for their medications. We do have generous programs that we provide, but given the fairly significant expansion in Repatha, Imavig, and Vanity coverage with a permanent J-code, we really have seen less need for those programs. However, that could change in the longer term as some of the patients who are currently furloughed could become displaced or laid off or as patients who may be securing COBRA could end up lapsing.

Keep you posted as opportunities develop.

Erika, let's take the next question and just a reminder to a participants if you can please limit yourself to one question.

Eric I'll go ahead.

Your next question is from Geoffrey Porges, what SVP Leerink.

Thank you. Thank you very much.

Right and the question and congratulations on concerning the business and trying circumstances.

Just to follow up on the other question on a captive.

Dave could you give us a sense of fault.

Very well powered study so what sort of hazard ratio or you are aiming for two achieved statistical significance and then more importantly, perhaps what sort of hazard ratio Pemex. What you think is clinically significant given.

Murdo: Also, many patients end up going off of their own benefits to a spousal benefit. So there are multiple layers of how people who are losing their insurance coverage might be able to bridge through different mechanisms. We're also hopeful and maybe even optimistic that some additional stimulus will be provided so that patients can seek continuity of their health care coverage. But, you know, overall, I would say so far so good despite significant disruption, obviously, in our economy.

Quite a few other promise that are advancing in that setting right now.

Yes. Thanks for the question you know what I would say is that you know this study is powered to detect what we would consider a clinically meaningful difference and outcome you know the primary endpoint as a standard for these sorts of trials is a composite you know heart failure events in Q.

Neovascular death.

On the order of 15%, we're so improvement on those measures is the sorts of things that are cardiologist I will typically look for in considered clinically meaningful in the study has been designed to detect those sorts of differences.

Bob: And on business development, Robyn, I wouldn't point to any changes in our approach. We've addressed this, I think, pretty consistently on prior calls.

Bob: We're looking for licensing or acquisition opportunities in the areas of our focus. So we'll continue, I think, in particular, scouring the licensing landscape at the moment. I'll keep you posted as opportunities develop.

Great. Thank you.

Your next question is from that with Evercore ISI.

Hi, Thanks, so much for taking my question I just wanted to focus on care ask for a second eight maybe gauge your expectations on durability of response, how you would prepare the street heading into your data and be if you could catch us up on whether there's any early evidence emerging on your be I'd dosing and if you're seeing.

Operator: Erika, let's take the next question, and just a reminder to our participants if you can please limit yourself to one question. Erika, go ahead.

Geoffrey Christopher Meacham: Your next question is from Geoffrey Porges with SVB Lyrinc.

Geoffrey Christopher Meacham: Thank you very much for taking the question and congratulations on continuing with the Business in Trying Circumstances. Just to follow up on the earlier question on Omer Kamtev, Dave, could you give us a sense of... It's going very well.

Possible efficacy differentiation with the higher you see it'd be I'd. Thank you.

Oh, thanks, similar in terms of duration of response.

Geoffrey Christopher Meacham: [inaudible]

So early as I mentioned, we're going to have an update on phase one data.

Geoffrey Christopher Meacham: What's the Hazard Ratio?

Geoffrey Christopher Meacham: [inaudible]

As Mo in roughly six or seven weeks.

David M. Reese: Gautam Raghavan, A. V. Gautam, A. R. Gautam, A. V. Gautam, A. V. Gautam, A.

And that by the time, we have those data sets will get some look at a duration.

You know and be I'd dosing, we continue to examine.

David M. Reese: And again, given quite a few other products that are advancing in that setting right now.

I would expect it's going to be later in the year or first part of the next year until we would have enough data to.

David M. Reese: Yeah, Geoff, thanks for the question. You know, what I would say is that, you know, the study is powered to detect what we would consider a clinically meaningful difference in outcome. The primary endpoint, as a standard for these sorts of trials, is a composite of heart failure events and cardiovascular death. On the order of 15% or so improvement on those measures is the sort of thing that cardiologists will typically look for. And consider this clinically meaningful. And the study has been designed to detect those sorts of differences. Great, thank you.

Thoroughly examine both safety and then whether there's any sort of efficacy difference.

Between monotherapy and be I'd dosing I would reiterate that based on everything we've seen we remain comfortable with the monotherapy dose that weve chosen to go forward with in terms of congrats inhibition in certainly in lung cancer that is our primary focus right now.

Thank you.

Your next question is from.

With Cantor Fitzgerald.

Hey, guys. Thanks for taking my question Congrats on the progress during the quarter. Another one on Mcandrew I know, there's roughly about 3 million people with heart failure with reduced ejection fraction of I was hoping murdo, maybe you could draw that down a little bit and help us think about maybe kind of an initial population based on how the size design thing.

Umer Raffat: Your next question is from Umer Raffat with Evercore ISI.

Umer Raffat: Hi, thanks so much for taking my questions. I just wanted to focus on CARE-ASK for a second. A, maybe gauge your expectations for durability of response, and how you would prepare the street heading into your data. And B, if you could catch us up on whether there's any...

Yes, Thanks, Felicia I would say this and Dave's already touched on it given that this is a slightly sicker population than some of the other recent heart failure trials. Our focus is really in the institutional setting.

Umer Raffat: Early evidence

Umer Raffat: Reddy Dosing.

Umer Raffat: And if you're seeing this...

Umer Raffat: And if you're seeing possible efficacy differentiation with the higher AUC at BID, thank you.

David M. Reese: Thanks, Umer. You know, in terms of the duration of response, you know, it's still early. As I mentioned, we're going to have an update on phase one data at ESMO in roughly six or seven weeks. So in that, you know, by the time we have those data sets, we'll get some look at duration. You know, in BID dosing, we continue to examine. I would expect it's going to be later in the year or first part of next year until we have enough data to thoroughly examine both safety and then whether there's any sort of efficacy difference between monotherapy and BID dosing. I would reiterate that, based on everything we've seen, we remain comfortable with the monotherapy dose that we've chosen to go forward with in terms of KRAS inhibition, and certainly in lung cancer, that is our primary focus right now.

We have made investments over the course of last year and this year to expand our cardiovascular hospital presence. We've established a cardiovascular account management team, who will focus really on the more so the more severe hospital frequent flyer, if you will Uh huh.

Failure patients, who really need some symptomatic improvement and need some functional improvement. So they can reduce the amount of hospitalization that they have we also think that's where quite frankly, the greatest value in treating heart failure can exist in the healthcare system. So hopefully we haven't successful trial at our hands.

David M. Reese: Thank you.

Because we still see a really good opportunity for that type of patient.

Unknown Attendee: Your next question is from Alethea Young with Cantor Fitzgerald.

Unknown Attendee: Hey guys, thanks for taking my questions. Congratulations on the progress during the quarter. Another one on Omacando. I know there are roughly about 3 million people with heart failure with a reduced injection fraction, but I was hoping, Murdo, maybe you could drill that down a little bit and help us think about maybe kind of an initial population based on how the study is designed.

And I would add to leave here that the trial includes initiation of therapy in both hospitalized patients and non hospitalized patients.

So as Murdo mentioned it is a little sicker population than some of the other trials.

I have read out recently in heart failure is typically the leading or top handful of causes of hospitalization in most countries now it's almost always the leading cause of rehospitalization within 30 days.

Murdo: Thanks.

Murdo: Yes, thanks, Alethea. I would say this, and Dave's already touched on it, given that this is a slightly thicker population than some of the other recent heart failure trials, our focus is really on the institutional setting. We have made investments over the course of last year and this year to expand our cardiovascular hospital presence. We've established a cardiovascular account management team who will focus really on the more severe hospital frequent flyer, if you will, heart failure patients who really need some symptomatic improvement and need some functional improvement so that they can reduce the amount of hospitalization that they require. We also think that's where, quite frankly, the greatest value in treating heart failure can exist in the healthcare system. So hopefully, we have a successful trial on our hands because we still see a really good opportunity for that type of patient.

Which has a huge ample economic implications.

And so as Murdo mentioned.

These factors.

Really have informed or thinking about how the drug might be position going forward.

Your next question is from Cory Kasimov with JP Morgan.

Hey, good afternoon, guys. Thanks for taking the question. This one's probably for Murdo curious if you anticipate a longer term tailwind for neulasta onpro that that might extend beyond cobot 19, given that more providers may see the value the product and that may have previously I'm, just curious if you're able to gather any feedback.

Back from the field on this front during the pandemic.

David M. Reese: And I would add, Alethea, that the trial includes initiation of therapy in both hospitalized patients and non-hospitalized patients. So, as Murdo mentioned, it is a slightly sicker population than some of the other trials that have come out recently. And heart failure is typically the leading or top handful of causes of hospitalization in most countries now. And it's almost always the leading cause of re-hospitalization within 30 days, which has huge economic implications. And so, as Murdo mentioned, these factors really have informed our thinking about how the drug might be positioned going forward.

Thanks, Corey the.

We experienced so far I mean, there's really theres two drivers of that tailwind you alluded to one is the overall utilization of long acting Filgrastim in general has gone up and then of course, the innovation that is on pro which allows patients to have less frequent visits to their site.

Care has driven some share preference for on pro I think we'll be able to hold a quite a bit of that improvement in our share, but I'm also hoping that oncologist remain vigilant and continue to eat to increase their usage of long acting filgrastim than general consistent with the NCCN Guy.

David M. Reese: Your next question is from Corey Kesimov with J.P. Morgan.

Unknown Attendee: Hey, good afternoon guys. Thanks for taking the question. This one's probably for Murdo.

Unknown Attendee: I'm curious if you anticipate a longer-term tailwind for NuLasta OnPro that might extend beyond COVID-19, given that more providers may see the value of the product than may have previously. Just curious if you're able to gather any feedback from the field on this front during the pandemic.

Lines are clearly as long as cold that is out there.

People should be using a care strategies to minimize.

Patients exposure.

Particularly I mean compromised patients exposure to risk and of course for on probably minimizing their exposure to the the site of care where they.

Murdo: Thanks, Corey. The experience so far, I mean, there's really two drivers of that tailwind you allude to. One is that the overall utilization of long-acting Fulgrastim in general has gone up. And then, of course, the innovation that is OnPro, which allows patients to have less frequent visits to their site of care, has driven some share preference for OnPro. I think we'll be able to hold quite a bit of that improvement in our share price.

They pick up in infection. So overall I think we're pretty enthusiastic about what we're seeing with neulasta and with on pro specifically.

Okay appreciate it.

Your next question is from Mohit Bansal with Citigroup.

Great. Thanks for taking my question and congrats on the progress one quick one on April Big up one of the Collin feedback we get from doctors is that many of these patients migraine patients get teacher by primary care physicians and not just by had expansionist I'd that maybe the reason why the penetration.

Murdo: But I'm also hoping that oncologists remain vigilant and continue to increase their usage of long-acting Fulgrastim in general consistent with the NCCN guidelines. Clearly, as long as COVID is out there, people should be using care strategies to minimize patients' exposure, particularly immune compromised patients' exposure to risk. And, of course, for OnPro, minimizing their exposure to the site of care where they may pick up an infection. So overall, I think we're pretty enthusiastic about what we're seeing with NILASTA and with OnPro specifically. Okay, I appreciate it.

Being low Fortys agings did that and.

How do you see claims had juicy geographies expanding to buy make it even possible.

And what could a company like engine could do to make it possible. Thank you.

Yes. Thanks, Mohit, we we do have experience with primary care physician promotion than we do have primary care.

Mohit Bansal: Thank you.

Mohit Bansal: Your next question is from Mohit Bansal with Citigroup.

Positions in our target audience and there are those that specialize in treating migraine become good at it and I would say that they're openness to using aim of Vega is actually quite good and quite high.

Mohit Bansal: Great, thanks for taking my question and congrats on the progress. One quick one on Amovig: one of the common feedback we get from doctors is that many of these patients, migraine patients, get treated by primary care, and not just for headaches. And that may be the reason why the penetration remains low for these ages. To that end, how do you see current sub-QCGRPs expanding to primary care? Is it even possible? And what could a company like Amgen do to make it? Thank you.

I think one point that I would I would make that's that's adjacent to what you're describing is.

We definitely saw in coal, but then even post coated some bottlenecking on the part of the neurologist and to some extent these headache clinics in getting caught up with patient care. After the March April period of covert disruption and so.

Murdo: Yes, thanks, Mohit. We do have experience with primary care physician promotion, and we do have primary care physicians in our target audience. And there are those that specialize in treating migraines that have become good at it. And I would say that their openness to using Imuvig is actually quite good and quite high.

I think.

We continue to watch that closely we're seeing good improvements, but this is a stretch specialty neurologists take care of a lot of different conditions as you know and the more we can expand care into primary care community based.

Treatment the better I think it'll be for the growth of the category. So I would align with your observation that we need to expand the prescribing population that physicians foresee GRP and I actually see that that's what's happening in our data.

Murdo: I think one point that I would make that's adjacent to what you're describing is we definitely saw in COVID and even post-COVID, some bottlenecking on the part of the neurologist and, to some extent, these headache clinics in getting caught up with patient care after the March and April period of COVID disruption. And so I think we continue to watch that closely. We're seeing good improvements, but this is a stretch. Specialized neurologists take care of a lot of different conditions, as you know, and the more we can expand care into primary care and community-based treatment, the better I think it'll be for the growth of the category. So I would align with your observation that we need to expand the prescribing population of physicians for CGRP, and I actually see that that's what's happening in our data. Great, thank you.

Great. Thank you.

Your next question is from a corner gold with Barclays.

Thank you and good afternoon, guys I've question for Peter I was hoping he could walk through the cost of goods progression in the quarter I appreciate the full year guidance, but in the quarter. I mean volume was up mid teens Biosimilars were up meaningfully I believe you a meaningful royalty on that and yet non-GAAP Cogs was only up 3% strictly sort of a cobot 19 related.

Ability that sort of downshift or is there some other nuance of missing or does that speak to some sort of broader cog story. Thank you.

Yeah. Thank you Carl Yeah on cost of goods sold it was just product mix in the first in the second quarter, rather and so we would expect it as we said to be consistent with.

Carter Gould: Your next question is from Carter Gould with Barclays.

2019 on an overall basis for the year.

Carter Gould: Thank you and good afternoon, guys.

Carter Gould: I have a question for Peter. I was hoping he could walk it through.

Your next question is from selling.

I wouldn't I do have securities.

Carter Gould: [inaudible]

Peter: Yeah, thank you, Carter. Yeah, on Cost of Goods Sold, it was just product mix in the first, or the second quarter, rather. And so we would expect it, as we said, to be consistent with 2019 on an overall basis for the year.

Great. Thanks, so much for the question guys and also throw in my my thanks for being a leader in the industry here shortly in the prepared remarks.

Those can follow suit as well.

I just had one question on a omecamtiv maybe for for David David sounds like you're pretty bold up on this trial work in hitting the 15% bogey that.

Salveen Richter: Your next question is from Salim Syed with Mizuho Securities.

Salveen Richter: Great. Thanks so much for the question, guys, and also throw in my thanks for being a leader in the industry here in shortening the prepared remarks. Hopefully, others can follow suit as well.

You mentioned I just want to know if there was one thing that you had to pick in the trial design, whether it's in the sicker patients you mentioned or maybe.

David M. Reese: I just had one question on Omicamptive, maybe for David. So, David, it sounds like you're pretty bulled up on this trial working and hitting the 15% bogey that you mentioned. This trial failed. I didn't hit that 15% bogey. I'm curious what you believe that reason would be.

Flight proponent elevation that we saw in cosmic if there was one reason why.

This trial failed.

And didn't hit that 15% Bowden I'm curious what do you believe that reason would be.

David M. Reese: Yeah, thanks. It's hard to speculate on a specific reason. You know, I, you know, look, advanced heart failure is high risk by its nature. And, you know, we fully recognize that we've done, methodologically, a very good trial. But, you know, at this point, it is up to the molecule and Mother Nature, and we're going to know that answer in a few months.

Yes. Thanks.

It's hard to speculate on a specific reason you know look advanced heart failure is high risk.

By its nature and we fully recognize that we think we've done methodologically very good trial.

But at this point this is off to the molecule in mother nature, and we're going to know that answer in a few months.

Dane Vincent Leone: Okay. All right. Thank you.

Okay alright, thank you.

Your next question is from Dana.

Dane Vincent Leone: Your next question is from Dane Leone with Raymond James.

Raymond James.

Dane Vincent Leone: Hi, thank you for taking the questions. Congratulations on navigating the difficult macro environment. So my one question: I just want to focus on Tesla. Clearly, the results in the mild to moderate psoriasis setting were good.

Hi, Thank you for taking the questions congrats on getting the difficult macro environment.

My one question I just wanted to focus on Tesla clearly the results in the mild moderate tries to setting we're good.

Dane Vincent Leone: You're building up an effort to go to market in that setting. The question we get is just how do you actually tackle that market from where the drug is being used now? And specifically and mechanistically, how are you going to open up the formularies to actually really unlock the more mild patient phenotype versus more of the moderate where you already do have penetration now? So I guess, one, on the label, how will it really read differently? And then two, how are you going to work with payers, and how is that going to change the formulary status?

You are building up.

An effort to go to market not setting.

The question, we get is just how do you actually tackle that market from where the drugs being used now and specifically in Mechanistically. How are you going to open up the formulary is to actually really unlock the more mild patient phenotype.

Versus more of the moderate where you already do out penetration now so.

Just one on the label how old it really read differently and open up and then to how are you going to work with payers and how's that going to change the formulary status.

Murdo: Thanks for the question, Dane. Overall, we see that there is a very large population of mild to moderate patients out there. But we're really focused on those patients that tend to have a larger surface area of the skin involved in their psoriasis, where they're really finding topical treatments incompatible with the nature of their disease and looking for something better, like an oral option. And I think, you know, given the strength of the results in the clinical trial, we feel that we would be able to target and motivate that population of patients to seek an alternative to topic Much the way Otesla is currently used today, which is post-topical pre-biologic, we think it's really a logical expansion of our current positioning.

Thanks for the question Daying overall, we see you know there's a very large population a mild to moderate patients out there, but we're really focused on those patients that tend to have larger surface area the skin.

Involved in their psoriasis, where they're really finding the topical treatments incompatible with the nature of their disease and looking for something better like an oral option and I think you know given the strength of the results in the clinical trial, we feel that we would be able to target and motivate that.

Population of patients to seek an alternative to topical treatments.

Much the way.

Tesla is currently used today, which is post topical pre biologic, we think it's really a logical expansion of our current positioning from Iraq interactions with prescribers. We've we've been encouraged by their enthusiasm for what Otezla may offer. These individuals these patients.

Murdo: From our interactions with prescribers, we've been encouraged by their enthusiasm for what Otesla might offer these individuals, these patients. The other thing I would say is that at the end of last year, we initiated a primary care promotional effort for Otesla, something that our legacy Celgene colleagues couldn't do or had not done. And we were able to try that out, and we actually saw a good promotional response there. So we have the ability, given the scale of our primary care field force, to add Otesla to the mix there. I think that will help grow our commercial presence. We also are cross-training all of our Enbrel field force on Otesla to ensure that we have a maximal presence for, hopefully, an approved indication in the not-too-distant future.

The other thing I would say is we did at the end of last year.

Initiate a primary care promotional effort on Otezla something that are legacy celgene colleagues could do or have not done and we were out we're able to try that out we actually saw good promotional response. There. So we have the ability given the scale of our primary care field force to add well.

He has led to the mix there I think that will help grow our commercial presence.

We also are cross training all of our end Brown field force on Otezla to ensure that we have maximal presence for.

Hopefully an approved indication that not too distant future.

Murdo: With respect to access, which you mentioned specifically, because of the very good cost-benefit of Otesla compared particularly to biologic options, we've actually got very good coverage in this patient population today, not mild to moderate, but in the moderate to severe patient population today that we think we will be able to expand without too much gross to net erosion. So we're feeling pretty good about this growth opportunity. I'm pleased with how Otesla has performed since we integrated it into our portfolio. It is performing ahead of our expectations in TRX, and that's with some nominal COVID pandemic impact overall.

With respect to access, which you mentioned specifically.

Because again.

Because of the.

Very good cost benefit of otezla compared to particularly to biologic options. We've actually got very good coverage in this patient population today not mild to moderate but in the moderate to severe patient population today that we think we will be able to expand without too much gross to net erosion. So we're feeling we're feeling for.

Do you get about this growth opportunity.

I'm pleased with title Tesla has performed since we are integrated into our portfolio.

It is performing ahead of our expectations and Trx and that's with the some nominal cobot pandemic impact on the overall dermatology category. So so far so good.

Operator: Thank you. We have four minutes remaining. Let's take one last question.

Eric. Thank you have four minutes from let's take one last question after which Bob is going to make some concluding comments.

Operator: Thank you. This is a four-minute video.

Michael Smith: Yes, your final question is from Michael Smith with Guggenheim Securities.

Yes. Your final question is from Michael Smith with Guggenheim Securities.

Hi, guys. Good afternoon, and thanks for squeezing and I had a follow up on that Calix program.

Michael Smith: Hey guys, good afternoon and thanks for squeezing in. I had a follow-up on the KRAS program. SOTO-RASF is obviously being also evaluated in multiple combinations with other agents. How do you see those various combinations positioned relative to each other? For example, if there are indication overlaps, such as in lung cancer, potentially? And secondly, I guess what we need to see from the Keytruda combination in lung cancer, which I believe is the most advanced in development, to advance that particular combination into the next development phase?

Most of US obviously being also evaluated and much more combinations with other agents.

How do you see those various combinations position relative to each other for example, if there's indication overlap such as in lung cancer potentially and secondly, I guess, what do we need to see from that Keytruda combination and lung cancer, which I believe as most advanced <unk>.

And development to advance that particular combination into the next that development phase.

David M. Reese: Yeah, thanks. Thank you for the question. You know, the combinations, as you indicate, would potentially cover a range of indications or diseases, as well as different lines of therapy. There may be partial overlap. As these data sets, you know, emerge, of course, we would go, you know, we would evaluate them and determine where we think the most promise lies. I think it's too early. It's early days, and too early to call horses there. You know, the Keytruda combinations started first, but there are a half dozen in the clinic now. And as we move along in the coming months, you know, we'll give guidance, and we'll look forward to sharing the data. We know there is interest in this program and for the entire field as this program moves forward. It continues to move quite quickly.

Yeah. Thanks.

For the question you know the combinations as you indicated you know would potentially cover a range of indications or diseases as well as different lines of therapy. Other maybe personal overlap as these datasets merge of course, we would go yes, we will evaluate them and determine where.

We think.

You know that the most promise wise I think it's too early it's early days.

Too early to call forces there.

The Keytruda combination started first but there are half dozen in the clinic now.

As we move along in the coming months, we'll give guidance and we'll look forward to sharing those data. We know there are not in their interest stuff for this program and for the entire field as this program moves forward. It continues to move quite quickly.

Great. Thanks appreciate it.

David M. Reese: [inaudible]

Bob: Great. Thanks. I appreciate it.

Bob: All right, everyone, we'll want to wrap up so that we can close here at the top of the hour as promised, but let me just simply thank you for your ongoing interest in our company. I know we're all operating in unprecedented times here, but we feel like we're in a strong position.

All right everyone will want to wrap up so that we can close your eyes to talk with the hours promise, but let me just simply thank you for your ongoing interest support of our company.

No. We're all operating an unprecedented times here, but.

Feel like weren't as strong position.

For a company well.

Grateful that our staff worldwide are engaged in yard in our mission even in this.

Okay.

Bob: Thank you again for your ongoing support. We will be available to answer your questions if you have any following the call. We look forward to connecting with you after the third quarter.

Time to find ourselves. So thank you again for your ongoing support will be available to answer your questions. If you have any follow them all.

Yeah.

Great. Thank you everybody.

Ladies and gentlemen, this concludes engines second quarter 2020 financial results Conference call you may now disconnect.

Operator: Great. Thank you, everybody.

Operator: Ladies and gentlemen, this concludes Amgen's second quarter 2020 financial results conference call. You may now disconnect.

[music].

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